Abdominal TraumaPhase 4BEFASTNCT05025449
BEFAST (Bubble-Enhanced FAST) for the Evaluation of Solid Organ Injury
A Phase 4 study testing Focused Assessment with Sonography for Trauma (FAST) and Bubble-Enhanced FAST (BEFAST) in people with Abdominal Trauma, run by Emory University at 1 site in United States.
Trial summary
The Focused Assessment with Sonography for Trauma (FAST) exam is widely used and accepted as part of advanced trauma life support (ATLS) protocol, but its low sensitivity for identifying solid organ injury in the absence of hemoperitoneum is a significant limitation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Trauma
- What is being tested?
- Focused Assessment with Sonography for Trauma (FAST) and Bubble-Enhanced FAST (BEFAST)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 267 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2021to 14 Sep 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical suspicion of intra-abdominal injury
- Presentation within 24 hours of injury
- Planned CT of the abdomen/pelvis within 24 hours
- Ability of patient or legally authorized representative to provide informed consent
Who cannot join
- Co-existing penetrating abdominal injury
- Known hypersensitivity reaction to contrast agent
- Pregnant patients
- Prisoners
- No appropriate IV Line able to be inserted
- Hemodynamic instability at time of enrollment (sustained systolic blood pressure < 90 mm Hg or sustained heart rate (HR) >120 despite initial resuscitation)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: BEFAST (Bubble-Enhanced FAST) for the Evaluation of Solid Organ Injury in Hemodynamically Stable Blunt Abdominal Trauma
The Focused Assessment with Sonography for Trauma (FAST) exam is widely used and accepted as part of advanced trauma life support (ATLS) protocol, but its low sensitivity for identifying solid organ injury in the absence of hemoperitoneum is a significant limitation. Contrast-enhanced ultrasound (CEUS) has the potential to significantly enhance the evaluation of the trauma patient with acute intra-abdominal injury through the use of intravascular microbubbles that allow direct visualization of lacerations to solid organs. European studies have demonstrated that ultrasound contrast markedly improves the sensitivity of ultrasound in detecting solid organ injury, when the exam is performed in the radiology suite. The researchers hypothesize that the bubble-enhanced FAST or BEFAST exam will be more sensitive than traditional FAST for identification of solid organ injury in hemodynamically stable blunt abdominal trauma patients when performed by emergency providers.
Read the detailed description
Blunt abdominal trauma, whether from motor vehicle crash, assault, fall, or recreational injury, is a leading cause of morbidity and mortality. According to the 2016 National Trauma Database, 12% of all patients with trauma admissions had abdominal trauma, the majority of which is blunt. The diagnosis of intra-abdominal injury due to blunt abdominal trauma can be challenging. The physical exam is unreliable in patients with altered mental status or with impairment due to drugs or alcohol. While computed tomography (CT) can rapidly and accurately diagnose injury, emergency physicians have raised concerns that the use of CT has become overly liberal. The risks of overutilization of CT in hemodynamically stable blunt abdominal trauma include increased health care costs, lengthy stays in the emergency department, risks of contrast-induced nephropathy and radiation-induced malignancy, and patient anxiety when "incidentalomas" are discovered that need extensive and often unnecessary workup.
The Focused Assessment with Sonography for Trauma (FAST) exam is widely used and accepted as part of the advanced trauma life support (ATLS) protocol, but its low sensitivity for identifying solid organ injury in the absence of hemoperitoneum is a significant limitation. Contrast-enhanced ultrasound (CEUS) has the potential to significantly enhance the evaluation of the trauma patient with acute intra-abdominal injury through the use of intravascular microbubbles that allow direct visualization of lacerations to solid organs.
In 2016, the Food and Drug Administration (FDA) approved Lumason (sulfur hexafluoride lipid-type A microsphere) for characterization of focal liver lesions with CEUS in both adult and pediatric patients, opening new areas of research in the United States. Lumason is a second generation contrast agent that is more stable than previous ultrasound contrast agents and does not require refrigeration. Although approved for intravascular and intravesical use, Lumason's use in a trauma exam is off-label in the United States.
After participants provide informed consent, a baseline FAST exam will be performed and documented. This exam will be distinct from the initial ATLS resuscitation FAST in order to avoid any interference in the trauma evaluation. If not already placed, an intravenous line will be established according to standard practice for trauma patients. Following the FAST exam, a bubble-enhanced FAST (BEFAST) exam will be performed using Lumason as the contrast agent. As part of the standard of care, participants will have a CT exam performed within 24 hours, which will provide the gold standard for diagnosis of solid organ trauma.
- Conditions
- Abdominal Trauma
- Being tested
- Focused Assessment with Sonography for Trauma (FAST), Bubble-Enhanced FAST (BEFAST)
- Keywords
- Ultrasound contrast, Solid organ injury, Blunt abdominal trauma
- Medical subject headings
- Abdominal Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focused Assessment with Sonography for Trauma (FAST)Diagnostic test
The Focused Assessment with Sonography for Trauma (FAST) exam is widely used and accepted as part of Advanced Trauma Life Support (ATLS) protocol. After consent, a baseline FAST exam will be performed and documented. This FAST will be distinct from the initial ATLS resuscitation FAST in order to avoid any interference in the trauma evaluation. The investigator will use a phased array or curvilinear transducer to record video of their baseline FAST exam.
Bubble-Enhanced FAST (BEFAST)Drug
Also called Lumason
Following the FAST exam and using the same machine, a BEFAST exam will be performed using a low mechanical index setting in contrast-specific imaging mode. A 2.4 mL IV dose of Lumason will be injected into the subject's IV, followed by saline flush. The contrast will be injected once for the right side of the body, and once for the left side of the body looking for disruptions in the normal enhancement pattern and evidence of active bleeding. To examine the right side of the body: the liver will be imaged first in arterial phase, followed by the right kidney, before returning to image the liver in venous phase. To examine the left side of the body: the pancreas will be imaged first, followed by the kidney and the spleen. The investigator will note evidence of solid organ injury, free fluid, or active extravasation on both sides of the body; lacerations will be graded by the American Association for the Surgery of Trauma (AAST) criteria.
| Study group | Role | What they receive |
|---|---|---|
| Non-enhanced FAST exam followed by BEFAST exam | Experimental | Participants in the emergency department with hemodynamically stable blunt abdominal trauma will receive the standard of care Focused Assessment with Sonography for Trauma (FAST) exam followed by a Bubble-Enhanced FAST exam. Receives: Diagnostic Test: Focused Assessment with Sonography for Trauma (FAST); Drug: Bubble-Enhanced FAST (BEFAST) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of Detecting Solid Organ Injury Measured as the Number of True Positives
The performance of the study exams will be assessed as the number of correctly identified solid organ injuries (true positives) detected by FAST exam and BEFAST exam. The presence of injury will be determined by the gold standard of a CT exam, conducted within 24 hours as part of the standard of care.
Measured: 1 Day of exam
Specificity of Detecting Solid Organ Injury Measured as the Number of True Negatives
The performance of the study exams is assessed as the percentage of correctly identified lack of solid organ injuries (true negatives) detected by FAST and BEFAST exams. The presence of solid organ injury is determined by the gold standard of a CT exam, conducted within 24 hours as part of the standard of care.
Measured: 1 Day of exam
Number of Enrolled Participants With Successful Exams
The number of successful, completed exams is used to determine whether emergency physicians can incorporate BEFAST evaluation at the point-of-care. The exam is considered complete if the participant tolerates the study without experiencing severe adverse events to contrast and the participant allows the provider to complete the scan, and if the exam results in images of adequate quality to answer the focused clinical question.
Measured: 1 Day of exam
Percent Agreement Between Raters
Emergency physicians' interpretations of the ultrasound exams are compared to interpretations of board-certified radiologists for the presence or absence of solid organ injury, free fluid, or active extravasation. Injured organs are graded per American Association for the Surgery of Trauma (AAST) criteria.
Measured: 1 Day of exam
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2021
- Study start30 Sep 2021
- Primary completion14 Sep 2023
- Study completion14 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Abdominal TraumaStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 267 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, Laura Oh, Emory University
- Investigators
- Laura Oh, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05025449
- Sponsor's protocol ID
- IRB00100619
- Acronym
- BEFAST
- Status last verified
- Sep 2024
- First submitted
- 26 Aug 2021
- Last updated
- 8 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data collected during the trial will be made available for sharing, after de-identification.
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BEFAST (Bubble-Enhanced FAST) for the Evaluation of Solid Organ Injury in Hemodynamically Stable Blunt Abdominal Trauma
- ClinicalTrials.gov ID
- NCT05025449
- Acronym / sponsor ID
- BEFAST / IRB00100619
- Conditions
- Abdominal Trauma
- Keywords
- Ultrasound contrast, Solid organ injury, Blunt abdominal trauma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 267 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 30 Sep 2021 (actual)
- Primary completion
- 14 Sep 2023 (actual)
- Study completion
- 14 Sep 2023 (actual)
- First posted
- 27 Aug 2021 (actual)
- Results
- Posted 8 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Focused Assessment with Sonography for Trauma (FAST) exam is widely used and accepted as part of advanced trauma life support (ATLS) protocol, but its low sensitivity for identifying solid organ injury in the absence of hemoperitoneum is a significant limitation. Contrast-enhanced ultrasound (CEUS) has the potential to significantly enhance the evaluation of the trauma patient with acute intra-abdominal injury through the use of intravascular microbubbles that allow direct visualization of lacerations to solid organs. European studies have demonstrated that ultrasound contrast markedly improves the sensitivity of ultrasound in detecting solid organ injury, when the exam is performed in the radiology suite. The researchers hypothesize that the bubble-enhanced FAST or BEFAST exam will be more sensitive than traditional FAST for identification of solid organ injury in hemodynamically stable blunt abdominal trauma patients when performed by emergency providers.
Detailed description
Blunt abdominal trauma, whether from motor vehicle crash, assault, fall, or recreational injury, is a leading cause of morbidity and mortality. According to the 2016 National Trauma Database, 12% of all patients with trauma admissions had abdominal trauma, the majority of which is blunt. The diagnosis of intra-abdominal injury due to blunt abdominal trauma can be challenging. The physical exam is unreliable in patients with altered mental status or with impairment due to drugs or alcohol. While computed tomography (CT) can rapidly and accurately diagnose injury, emergency physicians have raised concerns that the use of CT has become overly liberal. The risks of overutilization of CT in hemodynamically stable blunt abdominal trauma include increased health care costs, lengthy stays in the emergency department, risks of contrast-induced nephropathy and radiation-induced malignancy, and patient anxiety when "incidentalomas" are discovered that need extensive and often unnecessary workup.
The Focused Assessment with Sonography for Trauma (FAST) exam is widely used and accepted as part of the advanced trauma life support (ATLS) protocol, but its low sensitivity for identifying solid organ injury in the absence of hemoperitoneum is a significant limitation. Contrast-enhanced ultrasound (CEUS) has the potential to significantly enhance the evaluation of the trauma patient with acute intra-abdominal injury through the use of intravascular microbubbles that allow direct visualization of lacerations to solid organs.
In 2016, the Food and Drug Administration (FDA) approved Lumason (sulfur hexafluoride lipid-type A microsphere) for characterization of focal liver lesions with CEUS in both adult and pediatric patients, opening new areas of research in the United States. Lumason is a second generation contrast agent that is more stable than previous ultrasound contrast agents and does not require refrigeration. Although approved for intravascular and intravesical use, Lumason's use in a trauma exam is off-label in the United States.
After participants provide informed consent, a baseline FAST exam will be performed and documented. This exam will be distinct from the initial ATLS resuscitation FAST in order to avoid any interference in the trauma evaluation. If not already placed, an intravenous line will be established according to standard practice for trauma patients. Following the FAST exam, a bubble-enhanced FAST (BEFAST) exam will be performed using Lumason as the contrast agent. As part of the standard of care, participants will have a CT exam performed within 24 hours, which will provide the gold standard for diagnosis of solid organ trauma.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-enhanced FAST exam followed by BEFAST exam | Experimental | Diagnostic Test: Focused Assessment with Sonography for Trauma (FAST), Drug: Bubble-Enhanced FAST (BEFAST)Participants in the emergency department with hemodynamically stable blunt abdominal trauma will receive the standard of care Focused Assessment with Sonography for Trauma (FAST) exam followed by a Bubble-Enhanced FAST exam. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical suspicion of intra-abdominal injury
- Presentation within 24 hours of injury
- Planned CT of the abdomen/pelvis within 24 hours
- Ability of patient or legally authorized representative to provide informed consent
Key exclusion criteria (6 listed)
- Co-existing penetrating abdominal injury
- Known hypersensitivity reaction to contrast agent
- Pregnant patients
- Prisoners
- No appropriate IV Line able to be inserted
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Focused Assessment with Sonography for Trauma (FAST)The Focused Assessment with Sonography for Trauma (FAST) exam is widely used and accepted as part of Advanced Trauma Life Support (ATLS) protocol. After consent, a baseline FAST exam will be performed and documented. This FAST will be distinct from the initial ATLS resuscitation FAST in order to avoid any interference in the trauma evaluation. The investigator will use a phased array or curvilinear transducer to record video of their baseline FAST exam. | Diagnostic test | Non-enhanced FAST exam followed by BEFAST exam |
| Bubble-Enhanced FAST (BEFAST)Also: LumasonFollowing the FAST exam and using the same machine, a BEFAST exam will be performed using a low mechanical index setting in contrast-specific imaging mode. A 2.4 mL IV dose of Lumason will be injected into the subject's IV, followed by saline flush. The contrast will be injected once for the right side of the body, and once for the left side of the body looking for disruptions in the normal enhancement pattern and evidence of active bleeding. To examine the right side of the body: the liver will be imaged first in arterial phase, followed by the right kidney, before returning to image the liver in venous phase. To examine the left side of the body: the pancreas will be imaged first, followed by the kidney and the spleen. The investigator will note evidence of solid organ injury, free fluid, or active extravasation on both sides of the body; lacerations will be graded by the American Association for the Surgery of Trauma (AAST) criteria. | Drug | Non-enhanced FAST exam followed by BEFAST exam |
Primary outcome
Sensitivity of Detecting Solid Organ Injury Measured as the Number of True Positives
Time frame: 1 Day of exam
The performance of the study exams will be assessed as the number of correctly identified solid organ injuries (true positives) detected by FAST exam and BEFAST exam. The presence of injury will be determined by the gold standard of a CT exam, conducted within 24 hours as part of the standard of care.
Specificity of Detecting Solid Organ Injury Measured as the Number of True Negatives
Time frame: 1 Day of exam
The performance of the study exams is assessed as the percentage of correctly identified lack of solid organ injuries (true negatives) detected by FAST and BEFAST exams. The presence of solid organ injury is determined by the gold standard of a CT exam, conducted within 24 hours as part of the standard of care.
Number of Enrolled Participants With Successful Exams
Time frame: 1 Day of exam
The number of successful, completed exams is used to determine whether emergency physicians can incorporate BEFAST evaluation at the point-of-care. The exam is considered complete if the participant tolerates the study without experiencing severe adverse events to contrast and the participant allows the provider to complete the scan, and if the exam results in images of adequate quality to answer the focused clinical question.
Percent Agreement Between Raters
Time frame: 1 Day of exam
Emergency physicians' interpretations of the ultrasound exams are compared to interpretations of board-certified radiologists for the presence or absence of solid organ injury, free fluid, or active extravasation. Injured organs are graded per American Association for the Surgery of Trauma (AAST) criteria.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Individual participant data collected during the trial will be made available for sharing, after de-identification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Oh, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Focused Assessment with Sonography for Trauma (FAST) and Bubble-Enhanced FAST (BEFAST) in people with Abdominal Trauma, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of Detecting Solid Organ Injury Measured as the Number of True Positives (time frame: 1 Day of exam). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024.